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Medical Device Classification (EU MDR)

Determination of the Medical Device Classification and the corresponding classification rule is the first step in the EU CE Marking process. Based on the class and the rule of the device, the technical file and the Notified Body application can be filed.

 

According to the EU MDR 2017/745, Article 51, medical devices are classified into I, IIa, IIb, and III, considering their intended purposes and their inherent risks. The risk is incremental from class I to class III.

Medical Device Classification

Medical Device Classification with Examples!

Class 1 - Low Risk

Examples : Corrective glasses and frames, Manual wheelchairs

Type of Certification : Self Certification / Self Declaration

Class 1s Low Risk (Sterile)

Examples : Personal protection kits, Sterile Urine Bags, etc.

Type of Certification : Notified Body

Class 1m Low Risk (Measuring Body attributes)

Examples : Stethoscopes, Weighing Balance

Type of Certification : Notified Body

Class 1r Low Risk ( Reused Device)

Examples : Surgical forceps ( All type of SS/Tit surgical equipment’s sterilized and reused by hospitals)

Type of Certification : Notified Body

Class IIa - Medium Risk

Examples : Orthodontic wires, Surgical gloves, Lancets

Type of Certification : Notified Body

Class IIb - Medium to High Risk

Examples : Orthopedic nails and plates, Intra-ocular lens, Incubators for babies

Type of Certification : Notified Body

Class III - High Risk

Examples : Pacemakers, Prosthetic heart valves, Cardiovascular sutures, Brain spatulas, Drug-Device Combination products

 

Type of Certification : Notified Body

For detailed information about each risk class, and CE marking requirements, refer individual pages.

Medical Device Classification Rules!

As per Annex VIII of the MDR, the Classification Rules are as follows:

 

  • Rules 1- 4: Non-invasive Devices
  • Rules 5 – 8: Invasive Devices
  • Rules 9 – 13: Active Devices
  • Rules 14 – 22: Special Rules